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RECRUITING
NCT07908888
PHASE4

Efficacy and Safety of Polatuzumab Vedotin, Rituximab Combined With Reduced-dose Cyclophosphamide, Doxorubicin and Prednisone Regimen in the Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma: A Multicenter, Single-arm, Prospective Study

Sponsor: The First Hospital of Jilin University

View on ClinicalTrials.gov

Summary

This is a multicenter, single-arm, prospective study evaluating the efficacy and safety of polatuzumab vedotin and rituximab combined with a reduced-dose regimen of cyclophosphamide, doxorubicin and prednisone (Pola-R-miniCHP) as first-line treatment in elderly, frail patients with diffuse large B-cell lymphoma (DLBCL). The primary objective is to assess the 2-year progression-free survival (PFS) rate. Eligible participants are elderly patients with previously untreated DLBCL who are assessed as frail or with poor tolerance by comprehensive geriatric assessment.

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2026-10-15

Completion Date

2029-08-15

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DRUG

Polatuzumab Vedotin

Polatuzumab vedotin administered intravenously on Day 1 of each 21-day cycle for 6 induction cycles.

DRUG

Rituximab

Rituximab administered intravenously on Day 1 of each 21-day cycle during induction and consolidation.

DRUG

Cyclophosphamide

Reduced-dose cyclophosphamide administered intravenously on Day 2 of each 21-day cycle during induction.

DRUG

Doxorubicin

Doxorubicin administered intravenously on Day 2 of each 21-day cycle during induction.

DRUG

Prednisone

Prednisone administered orally on Days 2 to 6 of each 21-day cycle during induction.

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China